Reliability of Five Rapid D-Dimer Assays Compared to ELISA in the Exclusion of Deep Venous Thrombosis

Janssen, Mirian C. H.; Heebels, A.E.; Metz, M. de; Verbruggen, H.W.; Wollersheim, Hub; Janssen, Sven; Schuurmans, Macé M.; Nováková, I.R.O.

doi:10.1055/s-0038-1655950

Cited by 132 publications

(102 citation statements)

References 25 publications

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“…We believe the diagnosis of UAP at admission to the ED should be based on clinical factors such as history, physical examination, and electrocardiography, and not on blood markers. Moreover, the generally low specificity of the available D-dimer assays (ELISA, latex agglutination assay, turbidometric immunoassays) and their wide variations in sensitivity [16][17][18] preclude their use as a diagnostic tool [16,[19][20][21][22]. Because of the low interassay correlation [21,22] and the lack of a D-dimer reference standard, we used the ELISA, which is currently considered the gold-standard methodology.…”

Section: Discussionmentioning

confidence: 99%

Role of ELISA D‐dimer test in patients with unstable angina pectoris presenting at the emergency department with a normal electrocardiogram

Shitrit¹,

Shitrit²,

Rudensky³

et al. 2004

American J Hematol

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Patients with unstable angina pectoris and acute myocardial infarction have higher than normal D-dimer levels. The aim of the study was to determine the value of the D-dimer test in patients with unstable angina pectoris and a normal electrocardiogram on presentation at the emergency department. The study sample included 81 patients who met these criteria. Blood samples collected at admission were subjected to ELISA D-dimer. Findings were correlated with coronary risk factors, use of cardiac medications, blood levels of acute phase reactants (fibrinogen and C-reactive protein), cardiac enzymes levels, length of hospital stay, and catheterization findings. ELISA D-dimer levels were statistically significantly correlated with cardiac risk factors, namely male sex, older age, smoking, and hypertension (r = 0.25, P = 0.02; r = 0.43, P = 0.0001; r = 0.26, P = 0.03; r = 0.35, P = 0.002, respectively), in addition to use of cardiac medications (beta blockers, aspirin, nitrates), levels of acute phase reactants, length of stay, and catheterization findings. On multivariate analysis, only D-dimer level, age, and sex were predictors of length of stay (P = 0.018). The study suggests that D-dimer levels at admission to the emergency department may serve as an additional tool to predict the magnitude of unstable angina pectoris in patients with a normal electrocardiogram. Am.

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Section: Discussionmentioning

confidence: 99%

Role of ELISA D‐dimer test in patients with unstable angina pectoris presenting at the emergency department with a normal electrocardiogram

Shitrit¹,

Shitrit²,

Rudensky³

et al. 2004

American J Hematol

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“…Our review found results for the quantitative assays frequently reported at different cut points. In several studies the cut point was not determined a priori but instead was chosen retrospectively to maximize the sensitivity of the assay (19,(25)(26)(27).…”

Section: Differences Among D-dimer Assaysmentioning

confidence: 99%

D-Dimer Testing for Deep Venous Thrombosis: A Metaanalysis

Schectman²,

et al. 2004

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Background: The use of D-dimer assays as a rule-out test for deep venous thrombosis (DVT) is controversial.To clarify this issue we performed a systematic review of the relevant literature. Methods: We identified eligible studies, using MED-LINE entries from February 1995 through October 2003, supplemented by a review of bibliographies of relevant articles. Studies reporting accuracy evaluations comparing D-dimer test results with lower extremity ultrasound or venography in symptomatic patients with suspected acute DVT were selected for review. Two reviewers critically appraised each study independently according to previously established methodologic standards for diagnostic test research. Those studies judged to be of highest quality were designated Level 1. Results: The 23 Level 1 studies reported data on 21 different D-dimer assays. There was wide variation in assay sensitivity, specificity, and negative predictive values, and major differences in methodology of reviewed studies. A multivariate analysis of assay performance, controlling for sample size, DVT prevalence, reference standard, and patient mix, found few differences among the assays in effect on test performance as measured by diagnostic odds ratio. Increasing prevalence of DVT was associated with poorer test performance (P ‫؍‬ 0.01), whereas the choice of venography as the reference standard was associated with better test performance (P <0.005). Conclusions: Explanations for the wide variation in assay performance include differences in biochemical and technical characteristics of the assays, heterogeneity and small size of patient groups, and bias introduced by choice of reference standards. Assay sensitivity and negative predictive value were frequently <90%, un-

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“…D-dimers were measured with a widely used quantitative latex assay (Tinaquant; Roche GmbH), which reaches a sensitivity for detection of thromboembolic disease of Ͼ95%, with a cutoff value of 500 g/L. 14 …”

Section: D-dimer Analysismentioning

confidence: 99%

“…12,13 Techniques for the quantitative detection of circulating D-dimers have improved such that the assay is now inexpensive and readily available. 12,14 The aim of this study was to determine whether D-dimer measurement would be sensitive enough to reliably detect thrombosis in cerebral sinuses, a condition in which the clot volume is often considerably smaller than it is in extracranial venous thromboembolic disease.…”

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confidence: 99%

Do Normal D-dimer Levels Reliably Exclude Cerebral Sinus Thrombosis?

Kosinski

Mull²,

Schwarz³

et al. 2004

Stroke

104

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Background and Purpose-Cerebral sinus thrombosis (CST) needs to be considered in the differential diagnosis of all patients with acute headache. Early diagnosis is essential because early treatment may prevent morbidity and may even be life-saving. Definite exclusion, however, needs advanced neuroradiologic diagnostics, which are not readily available in many hospitals. Because measurement of D-dimers has been demonstrated to be helpful in excluding thromboembolic disease, our aim was to investigate whether D-dimers would be also sensitive enough to exclude CST. Methods-We undertook a prospective multicenter study over a 2.5-year period including all patients who came to the emergency departments with symptoms suggestive of CST. All patients were diagnosed either by magnetic resonance venography, spiral computed tomography scan venography, or intra-arterial digital subtraction angiography. D-dimer levels were measured at admission and analyzed by the same method in all patients. Results-A total of 343 patients were included. CST was diagnosed in 35 patients, of whom 34 had D-dimers above the cutoff value (Ͼ500 g/L). From the 308 patients not having CST, D-dimers were elevated in 27. Sensitivity of D-dimers was 97.1%, with a negative predictive value of 99.6%. Specificity was 91.2%, with a positive predictive value of 55.7%. D-dimers were positively correlated with the extent of the thrombosis and negatively correlated with the duration of symptoms (Spearman rank correlation coefficients 0.76, Ϫ0.58, respectively). Conclusions-D-dimer

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Reliability of Five Rapid D-Dimer Assays Compared to ELISA in the Exclusion of Deep Venous Thrombosis

Cited by 132 publications

References 25 publications

Role of ELISA D‐dimer test in patients with unstable angina pectoris presenting at the emergency department with a normal electrocardiogram

Role of ELISA D‐dimer test in patients with unstable angina pectoris presenting at the emergency department with a normal electrocardiogram

D-Dimer Testing for Deep Venous Thrombosis: A Metaanalysis

Do Normal D-dimer Levels Reliably Exclude Cerebral Sinus Thrombosis?

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